In a successful week for the medical technology companies in the LSI Alumni community, we saw LSI Alumni achieve regulatory approvals, receive new funding, appoint new executives, launch partnerships, and much more on the road to LSI Europe ‘26 in Barcelona (September 28 - October 1).
Appointed Luc Verhees as Chief Clinical Officer. Verhees brings more than 30 years of experience in cardiovascular clinical research, with senior positions at leading global medtech companies and private venture-backed companies.
Announced the final closing of the MED IV fund at its €1.5B hard cap. Launched in January 2026 with an original target of €1.2B, the fund closed in less than six months and was three times oversubscribed, reflecting strong, sustained demand from existing and new investors.
Received FDA 510(k) clearance for its ActivaScrew™ Cannulated COM bioabsorbable compression screw. The clearance covers the fixation of bone and osteochondral fractures, osteotomies, arthrodeses, and bone grafts of the upper (hand, non-diaphyseal arm & forearm) and lower (foot, non-diaphyseal ankle) extremities in the presence of appropriate immobilization.
Received an undisclosed investment from Gopher Angels and NuFund Venture Group. The company’s annular repair technology is designed to treat the main cause of functional regurgitation, leaving the healthy leaflets intact to perform as intended, and is currently focused on the Tricuspid valve.
Received FDA 510(k) clearance for the CraniUS Plate, a patient-specific cranioplasty implant intended for the repair of cranial defects. Each CraniUS Plate is designed and manufactured to match the individual patient's anatomy, giving neurosurgeons and craniofacial surgeons a patient-specific option for reconstructing cranial defects resulting from trauma, tumor resection, decompressive craniectomy, and other causes.
Closed $5M in additional Series B funding, including institutional and strategic investors, alongside a $1M community investment round through Wefunder. The funding will support the company’s expanded U.S. commercial reach through four new partnerships across primary care, enterprise healthcare, and federal health systems, helping bring its AI-powered skin cancer risk detection technology to more providers and patients nationwide.
Received FDA 510(k) clearance for the Emboliner® Embolic Protection System for use during transcatheter heart procedures. The Emboliner is indicated for use as an embolic protection device to capture and remove embolic material during transcatheter aortic valve replacement.
Nominated Jean-Pierre Desmarais as an independent director on its Board of Directors. Desmarais brings more than four decades of experience in the medical device industry, spanning R&D, clinical research, regulatory affairs, and global commercialization.
Secured FDA clearance expanding the capabilities of VERAFEYE, its procedural intelligence platform. The system reconstructs 3D models of the left and right atria with CT-like accuracy, allows physicians to visualize and document ablation delivery directly on the anatomy, and maintains continuous visibility of both imaging and ablation catheters through electromagnetic tracking and automated imaging.
Received an investment from Jetstream Venture Fund. The company aims to automate complex Doppler ultrasound assessments and pedal acceleration time calculations, empowering front-line clinicians to evaluate vascular health accurately without requiring specialized sonographers.
Secured a €25M growth debt financing facility from Claret Capital Partners. The financing will support the continued commercial expansion of NEUROMARK®, accelerate investment in sales and marketing initiatives, strengthen the company’s balance sheet, and provide additional capital to support future growth opportunities.
Received FDA Breakthrough Device Designation for its first product in development, a wearable designed for vancomycin therapeutic drug monitoring. The company plans to expand its DNA-based sensing platform to multiple analytes, including sensors targeting molecules involved in the diagnosis and management of sepsis and cardiovascular disease.
Welcomed Jared Slibeck as Chief Commercial Officer. Slibeck brings more than 20 years of experience in surgical navigation and enabling technology, including a distinguished career at Stryker working across neurosurgery, spine, ENT, orthopedics, oncology, and trauma.
Entered into an exclusive collaboration with ALM Ortho to introduce bespoke titanium implants for severe shoulder deformity and complex revision cases. Shoulder Innovations holds exclusive U.S. rights for upper extremity applications, while leveraging its surgeon relationships and sales organization to identify cases and connect surgeons with ALM Ortho’s design and manufacturing capabilities.
Announced complete six-month results from the DEScover Phase II study evaluating the investigational Solaris DE sirolimus-eluting covered stent for dialysis access dysfunction. Solaris DE demonstrated 92.7% overall target lesion primary patency and 79.9% overall access circuit primary patency, while meeting its primary safety endpoint with 97.3% freedom from access- or venous outflow circuit-related safety events at 30 days.
Appointed Sean Salmon to its Board of Directors, bringing more than two decades of leadership experience at Medtronic, most recently as EVP and President of its Cardiovascular portfolio. Since leaving Medtronic in 2025, Salmon has served as a board member, advisor, and consultant in medtech, including joining Adagio Medical’s board.
Received FDA Breakthrough Device Designation for its Iris Surgical Robotic System for remote robotic-assisted mechanical thrombectomy in patients with acute ischemic stroke. The designation provides increased opportunities for the company to interact with FDA experts and receive support during the regulatory development and review process as the company advances the Iris System.
Stay tuned for more updates, insights, and achievements of our LSI Alumni in The Weekly Recap, and follow our blog for the latest medical device news and advancements.
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